1. Technical Field
The present invention relates to an improved container for sterilization, storage, and presentation of surgical instruments and materials, and, more particularly, to a sterilization, storage, and presentation container which includes removable insert boards and retainer systems to which the surgical instruments and materials are releasably mounted. Dividers and synthetic foam systems, as well as pegs and clip retainers, removably secured to the insert boards, provide the mounting system for the surgical instruments and materials. The container of the present invention is especially well-suited for use with a sterilization wrap.
2. Background Information
Surgery involves highly complex procedures which are accomplished with a significant number of specialized instruments and devices. Any instrument or device used by the surgeon during a surgical procedure must be readily available and presented in an orderly, readily accessible manner. It is clearly understood, of course, that such instruments and devices also must be presented in a sterile condition. Presentation is next in importance to sterility, since many surgical procedures require prompt access to certain instruments, the absence of which could result in serious injury, or even death, to the patient.
It is customery to provide the appropriate types and quantities of surgical instruments and materials for a specific surgical procedure as a unitary package that previously has been sterilized and maintained in a sterile condition by reason of the packaging system employed. Such sterilization and maintenance in general are accomplished by one of three methods, described below.
The earliest and most simple method for sterilizing surgical instruments and materials, which still is used to a limited extent today, involves directly wrapping the articles in at least one sheet of a porous material, such as paper, a towel, muslin, or a disposable, nonwoven fabric, sealing the wrapped package with tape, and placing the package in a sterilizing autoclave. Sterilizing medium enters the autoclave chamber and penetrates the porous material of the package to contact the articles contained within. Some autoclaves provide for the removal of air before introduction of the sterilization medium and/or the removal of moisture after autoclaving by means of a vacuum-drying cycle. With most of such autoclaves, atmospheric pressure is restored within the autoclaves by admitting room air prior to removal of the package placed therein.
While relatively simple, the above method did not make the surgical instruments and materials readily accessible in an orderly manner. Unless multiple layers of wrapping were employed, contamination by microorganisms or particles of wrapping was a frequent occurrence. Furthermore, the shelf life of the sterilized package was relatively short, necessitating resterilization prior to use. Another consequence commonly resulting from the use of the above method was the loss of or damage to expensive instruments. Frequently, the wrapping is spread out on a table in an operating room and the instruments are placed thereon after use. Subsequently, the wrapping is gathered up and disposed of, or set aside for reuse. Unless the instruments are meticulosly removed from the wrapping, they can be lost or damaged.
In order to obviate some of the disadvantages associated with the foregoing method, the surgical instruments and materials were placed in open trays, with or without lids. The trays then were wrapped and sterilized, as with the first method. The advantage to this method is that the instruments can be organized for presentation, and the tray provides a receptacle for the collection of used instruments. See, by way of illustration only, U.S. Pat. No. 2,384,398, which describes a sterilization container. The container consists primarily of an outer casing and an inner basket, with the basket being placed in a porous bag which provides the barrier against microorganisms upon the completion of sterilization.
A variation of the foregoing is described in U.S. Pat. No. 4,466,552, which describes a sterilization container formed of a nonwoven material. In this case, however, the nonwoven material has been treated with a resin, thereby giving the container sufficient rigidity to permit its use in the same way as a metal or plastic container. The nonwoven material remains porous, thereby facilitating sterilization, but still serves as a barrier against microorganisms.
More recently, rigid containers have been developed which do not require an external sterilization wrap. Examples of such containers are found in the reference described below.
German Patent Application No. P 22 07 339.8-41, published as No. 2 207 339, describes a surgical instrument container closed by a lid and having a perforated bottom which can be covered by a filter. The container has an intermediate frame forming the sidewalls and the perforated bottom is releasably connected to this frame. A support frame inside the intermediate frame extends over the opening left when the bottom is removed.
A variation of the above-described container is found in French Pat. No. 2,375,869. Either or both of the base and cover of the described sterilization container can be perforated and covered on their inside face with a fabric or paper filter, held in place by the convex side of a perforated pressure plate of slightly cylindrical curvature against such inside face.
U.S. Pat. No. 4,105,407, describes a sterilizing container having a lid with an outer flange which cooperates with the upper edge of a base and a resilient member for sealing the container. The lid contains a mechanism for automatically moving the lid into sealing engagement with the base. The container is designed to receive articles such as medical instruments which are sterilized when the container is placed in an autoclave, subjecting the instruments or articles to a sterilizing environment. The moving mechanism on the lid includes a means responsive to the sterilizing environment to automatically bring the lid into sealing contact with the base prior to the return of the surrounding environment to ambient conditions, thereby preserving the instruments in a sterile condition until needed for use. Variations of this container are described in U.S. Pat. Nos. 4,247,517 and 4,372,921. Moreover, containers embodying one or more of the features described in the foregoing references are available commercially from such companies as American Container Technology, Inc., Wallington, N.J. 07057; Aesculap Instruments Corporation, Burlingame, Calif. 94010; InstruMed, Inc., Kirkland, Wash. 90834; American Sterilizer Company, Erie, Pa. 16506; Martin U.S.A., Inc., Stamford, Conn. 06902; and Genesis Medical Corporation, Cleveland, Ohio 44130.
The open trays and rigid containers described above range from relatively simple devices, such as a closed container, having apertures therein or a sieve placed in the bottom on the container for entry of a sterilizing agent, to complex devices, such as containers provided with elaborate mechanisms for closing the cover of the device after a sterilizing gas has had sufficient time to enter the container. Other containers, intermediate in complexity between the aforementioned devices, are those sterilization containers having apertures passing from an outer surface to an inner surface of the container and provided with a porous material covering one of the apertured surfaces. The porous material is selected to permit passage of air and other gases, but to be impervious to the passage of microorganisms. All of such devices are intended to provide ingress and egress of air or a sterilizing gas during the sterilization procedure, but to exclude contaminants during and subsequent to the sterilization procedure.
As already noted, presentation is important since it displays the various instruments in a readily accessible format. Further, it is critical that certain types of surgical instruments and devices such as prosthetics are adequately protected during sterilization, storage, and handling, as well as being readily available during presentation.